Implantable medical devices that are delivered to a point of treatment using a delivery system must be loaded into the delivery system at some point prior to the implantation procedure. For some devices, this loading step can occur during the manufacturing process without adversely affecting the performance of the device. For example, expandable stents are typically loaded into their delivery system during the manufacturing process. When performing the implantation procedure, the clinician need not load the implantable medical device into the delivery system. Rather, the delivery system is simply removed from its packaging and put into use.
For some implantable medical devices, however, various concerns exist about the potential effects of extended storage within a delivery system. For example, it is well known that some medical device materials, such as tissues and biological-derived products, perform better when stored under hydrating conditions or in a hydrated state. Also, the long-term memory effects of reduced-diameter storage on some materials is not yet well understood, making it undesirable to store some devices in a delivery system prior to use.
For these implantable medical devices, it is sometimes necessary to store the device in a temporary storage vessel and instruct clinical personnel to load the device into an appropriate delivery system prior to the implantation procedure. Such storage and loading can even be used for those devices in which storage in a delivery system is not particularly undesirable. For example, storing stents separately from delivery systems may make it easier for clinicians to assemble device/delivery system combinations tailored to a particular patient and/or clinical presentation. For all instances in which a clinician must load the implantable device into a delivery system prior to implantation, it is desirable to make such loading procedures as simple and repeatable as possible.
Thus, a need exists for temporary storage and loading systems for implantable medical devices, methods of preparing an implantable medical device for implantation in a patient, and kits useful for the storage and loading of implantable medical devices.